December 4–6, 2017
Boston, US

Day One
Monday, December 4 2017

Day Two
Tuesday, December 5 2017

Coffee & Registration

Chairs Opening Remarks

The Critical Step – Sterilization for a Safe Product

Case Study: Develop a Robust Formulation and Fill Finish Process to Ensure a Smooth Scale Up and Tech Transfer for Drug Product Manufacturing

  • Mark Yang Director of Fill-Finish, Sanofi Genzyme


• Drug product development starts with high quality and stable drug substance
• Develop a robust bioformulation
• Align early and late stage development for a lasting fill finish process
• Risk mitigation during process scale up and technology transfer
• New technologies and their incorporation for a controlled and consistent fill finish operation

GMP Compliance for Aging Equipment


• The reality of aging equipment – cGMP challenges for older lyophilizers and other aseptic processing equipment
• How to perform inspection and audits
• Collecting data for quality control of machinery performance and operations
• Evaluating your options: Continuous improvement, renovate or replace

Morning Refreshments & Networking

Ensuring Product Integrity through Advanced Engineering

Compounding Pharmacy Transition (503a to 503b) – From Small Batch to Commercial Sterile Manufacturing


• Aseptic process control and considerations during scale-up
• Define your critical quality attributes to ensure compliance
• Understanding the regulatory guidance for pharmacy sterile products and comparing to GMP, and look beyond for future direction

Master Mind: How to Work with Your Internal and External Partners to Enhance AP & Sterility Quality?


The following areas have drawn industry leaders’ attention:

• AP and sterilization knowledge and technical skill gap
• Industry standardization of AP and sterilization SOPs
• CMO capability, capacity and cost

The audience will be split into small groups for a knowledge sharing.

Utilize this master mind session to brainstorm and inspire each other for steps required to overcome these issues. Develop an action plan based on your experience and we will share your thoughts at the end of this session.

Lunch & Networking

Mapping Validation Considerations from Process Development to Product Launch and Beyond

  • Sabrina Restrepo Director – Sterile & Validation Center of Excellence , Merck


• From proof-of-concept to defining a clear framework of validation strategy
• What are the evaluation criteria?
• A quality validation for quality risk management
• Why this is important to successful product launch and patient safety

Container-Closure Integrity Testing for Parenteral Drug Products: Evolving with the Changing Regulatory Landscape

  • Dominic DeGrazio Associate Scientist- Large Molecule Drug Product Development, Janssen


  • Comparison of US and EU regulatory instructions on sterile, parenteral packages
  • Development of integral packaging systems using QbD and relationship to CCIT
  • Holistic approach to evaluate CCIT for combination products throughout lifecycle
  • Future of CCIT for commercial drug product upon fill-finish manufacturing and stability

Chair’s Closing Remarks